MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-13 for TECNIS 1 MULTIFOCAL ZKB00 ZKB00U0210 manufactured by Johnson & Johnson Surgical Vision, Inc..
[183373884]
Date of event: exact date not provided, best estimate is between (b)(6) 2018 - (b)(6) 2020. (b)(4). Note: the device was manufactured at the (b)(4) site which has been closed. All pertinent information available to johnson & johnson surgical vision, inc. Has been submitted.
Patient Sequence No: 1, Text Type: N, H10
[183373885]
It was reported that a zkb00 intraocular lens (iol) was explanted from the left eye due to patient seeing halos. The explanted lens was replaced with a non-johnson and johnson iol, but same diopter. There was no incision enlargement, no vitrectomy, no sutures required. The patient was fine post-op. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020664-2020-00022 |
| MDR Report Key | 9827887 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-13 |
| Date of Report | 2020-03-12 |
| Report Date | 2005-01-01 |
| Date Reported to FDA | 2005-01-01 |
| Date Reported to Mfgr | 2005-01-10 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SOMYATA NAGPAL |
| Manufacturer Street | 1700 EAST ST. ANDREW PLACE |
| Manufacturer City | SANTA ANA CA 92705 |
| Manufacturer Country | US |
| Manufacturer Postal | 92705 |
| Manufacturer Phone | 7142478200 |
| Manufacturer G1 | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Street | LOT H.S (D) 70252, PT 2489 JALAN HI TECH 11, INDUSTRIAL Z |
| Manufacturer City | KULIM HI TECH PARK 09000 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 09000 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECNIS 1 MULTIFOCAL |
| Generic Name | MULTIFOCAL IOLS |
| Product Code | MFK |
| Date Received | 2020-03-13 |
| Model Number | ZKB00 |
| Catalog Number | ZKB00U0210 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JOHNSON & JOHNSON SURGICAL VISION, INC. |
| Manufacturer Address | 1700 E ST ANDREW PLACE SANTA ANA CA 92705 US 92705 |
| Product Code | --- |
| Date Received | 2020-03-13 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-13 |